Chief Operating Officer (COO)
Job Description
Regulatory, Quality, Manufacturing & Operational Delivery
\nReports to: Chief Executive Officer
\nRole Purpose
\nScubaTx is entering a delivery‑critical execution phase, spanning ISO 13485 certification, FDA 510(k) preparation, verification and validation (V&V), supply‑chain establishment, and manufacturing readiness for US launch.
\nWe are appointing a Chief Operating Officer (COO) to act as the single named execution owner across operational delivery, quality, regulatory readiness, manufacturing, and supply chain. This role exists to convert strategy and plans into evidence, artefacts, and predictable execution, enabling the CEO and CSO to focus on strategy, fundraising, and scientific leadership.
\nThis is not a coordination or PMO role. The COO holds real authority, is accountable for delivery outcomes, and is expected to actively manage plans, respond to real‑world constraints, and propose corrective actions to the Senior Management Team (SMT).
\nThe COO is Accountable and Responsible (A/R) for industry‑standard MedTech execution ownership, including:
\nISO 13485 Quality Management System (QMS) implementation, maintenance, and audit readiness
\nDesign History File (DHF) integrity, traceability, and audit‑defensibility
\nVerification & Validation (V&V) strategy, planning, and execution
\nDesign controls, risk management (ISO 14971), and associated regulatory artefacts
\nManufacturing and supply‑chain readiness through early scale‑up
\nIntegration of regulatory, manufacturing, and commercial timelines into a single delivery plan
\nOperational delivery cadence with clear, board‑ready reporting
\nExecution ownership is internal, explicit, and non‑delegable, even where specialist activities are delivered by consultants or suppliers.
\nKey Responsibilities
\nQuality, Regulatory & Compliance Execution
\nOwn end‑to‑end delivery of the ISO 13485 QMS, from definition through certification and maintenance
\nMaintain continuous audit readiness across documentation, processes, and behaviours
\nOwn DHF completeness, design control alignment, and traceability
\nOwn V&V strategy, schedules, dependencies, and evidence generation
\nAct as senior internal owner of FDA 21 CFR 820‑aligned operational readiness
\nLead, manage, and challenge external QA/RA consultants against defined scope, milestones, and outputs
\nManufacturing & Supply‑Chain Readiness
\nDefine manufacturing and supply‑chain strategy from first principles (UK vs US vs ROW; in‑house vs outsourced)
\nLead supplier identification, qualification, and onboarding
\nNegotiate and manage supplier contracts from an operational, quality, and delivery perspective, in alignment with CFO‑owned commercial terms, payment structures, and cash constraints
\nEstablish supplier quality agreements and incoming inspection strategies
\nEnsure manufacturing and supply‑chain readiness is aligned with regulatory submissions and US launch plans
\nIntegrated Delivery & Complex Programme Management
\nBuild, own, and continuously manage the integrated operational delivery plan across:
\nQuality & regulatory milestones
\nV&V execution
\nSupply‑chain and manufacturing readiness
\nActively manage delivery in response to real‑world challenges, constraints, or failures
\nProactively surface delivery risks, trade‑offs, and mitigation options to the SMT
\nDrive corrective actions and reset plans where required to protect outcomes
\nPartner with the CFO to assess delivery risks with material cash, cost, or runway implications, ensuring timely escalation and coordinated recommendations to the SMT and Board
\nOperational Governance & Cadence
\nEstablish and own a clear operational execution cadence
\nProduce board‑ready operational updates, dashboards, and evidence packs
\nEnsure decisions are presented with clear options, implications, and recommendations
\nMaintain alignment between the integrated delivery plan and the CFO‑owned financial plan, ensuring a single, consistent view of timelines, risks, and trade‑offs at board level
\nExecutive Leadership & Continuity
\nMaintain operational momentum, decision clarity, and team confidence
\nRepresent ScubaTx with auditors, suppliers, partners, and investors as required
\nChampion disciplined execution culture across the organisation
\nOversight Interfaces
\nCEO: Strategic direction, escalation, and resource prioritisation
\nCSO: Scientific and clinical risk input (consulted)
\nTechnical Director: Engineering design authority and change control (consulted)
\nCFO: Cash stewardship, supplier payment governance, capital and cost discipline (aligned)
\nThe COO owns operational execution and delivery outcomes.
\nExperience & Profile
\nSenior operational leadership experience in regulated medical device environments
\nProven ownership of complex, cross‑functional delivery programmes
\nDemonstrated delivery of ISO 13485 QMS implementation and audit readiness
\nHands‑on experience with DHF, V&V, design controls, and risk management
\nManufacturing and supply‑chain establishment and supplier qualification experience
\nStrong complex programme / delivery management capability
\nComfortable operating autonomously with executive authority and accountability
\nStartup or scale‑up MedTech background
\nPrior COO, Head of Operations, or equivalent senior execution role
\nStage Expectations
\nThis is a hands‑on COO role during a delivery‑critical phase, requiring active management of plans, people, and problems. The role is expected to evolve as ScubaTx progresses from regulatory readiness into early commercial execution and scale.
\nSalary Expectation
\nCompetitive salary, depending on experience, plus participation in the company’s equity incentive scheme.
\nScubaTx’s success over the next phase depends on disciplined execution under regulatory, manufacturing, and supply‑chain constraints. The COO will be the executive who ensures that what is promised is built, evidenced, and ready on time.
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